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Clinical Trials in Sweden / NCT05637112
Active, not recruiting Observational

A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice.

NCT05637112 · tracked via the Priya Life Science Sweden tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2023-02-27
Last updated
2026-09-24

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

None (Observational study)

None (Observational study): Not Applicable since Observational Study

Study summary

Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Fulfilled the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology) criteria for SLE at the time of study entry. * Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label. * The Physician's decision to prescribe anifrolumab must occur prior to any study-related discussion. * In countries where prescription reimbursements are authorised on a case-by-case basis, authorisation (ie, patient access to treatment) will be required for study entry. Exclusion Criteria: * Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product. * Any previous exposure to anifrolumab (including as part of a clinical trial or early access programme). * Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide \[CYC\] + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, ie. skin/joint involvement), or active severe or unstable neuropsychiatric lupus. * Any other condition which the investigator deems to limit a patient's ability to understand the informed consent.

Primary outcome measure(s)

  • Disease activity assessed by the Physician Global Assessment (PGA) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
    The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).
  • Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
    The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity.
  • Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
    The proportion of patients attaining the composite endpoint of LLDAS will be assesed.

Trial sites (74)

FacilityCityRegionStatus
Research Site Innsbruck Tyrol
Research Site Linz Upper Austria
Research Site Vienna Austria
Research Site Liège Li Ge
Research Site Leuven Belgium
Research Site Calgary Alberta
Research Site Winnipeg Manitoba
Research Site Hamilton Ontario
Research Site Orillia Ontario
Research Site Toronto Ontario
Research Site Rimouski Quebec
Research Site Sherbrooke Quebec
Research Site Ste-Foy Quebec
Research Site Nice Alpes-Maritimes
Research Site Clermont-Ferrand Auvergne-Rh ne-Alpes
Research Site Strasbourg Bas-Rhin
Research Site Finist Re Brest Cedex
Research Site Dijon C te-d'Or
Research Site Bordeaux Gironde
Research Site Grenoble Is Re
Research Site Saint-Denis La R Union
Research Site Nantes Loire-Atlantique
Research Site Bouches-du-Rh Ne Lyon
Research Site FORT de France Cedex Martinique
Research Site Lille Nord
Research Site Seine-Maritime Rouen
Research Site Paris France
Research Site Paris France
Research Site Paris France
Research Site Paris France
Research Site Paris France
Research Site Heidelberg Baden-W Rttemberg
Research Site Heidelberg Baden-Wurttemberg
Research Site Erlangen Bavaria
Research Site Bad Bramstedt Free and Hanseatic City of Hamburg
Research Site Schleswig-Holstein L Beck
Research Site Greifswald Mecklenburg-Vorpommern
Research Site Cologne North Rhine-Westphalia
Research Site D Sseldorf North Rhine-Westphalia
Research Site Herne North Rhine-Westphalia

+ 34 more sites — see the full list on the official registry below.

More AstraZeneca trials in Sweden

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Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy Active, not recruiting
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) Active, not recruiting
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus Recruiting

Other trials for the same condition

The Anifrolumab PRIM Program Recruiting
Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05637112 on ClinicalTrials.gov ↗ ← All trials in Sweden